FEI 3002808382
Canon Inc.
1385, SHIMOISHIGAMI, OTAWARA-SHI Tochigi, JP
MDR events415All time
Recalls2All time
Registered products22
Establishment typeManufactureManufacture Medical Device
Registered product codes
22 product codes
Recent MDR events
415 on file
- CANONJun 26, 2026Malfunction2020563-2026-00006
- AQUILION 64May 15, 2026Malfunction25183569
- CANON INC.May 14, 2026Malfunction2020563-2026-00005
- CANONApr 2, 2026Malfunction2020563-2026-00004
- CanonMar 24, 2026Injury2020563-2026-00003
- CANONFeb 26, 2026Injury2020563-2026-00001
- CANONJan 5, 2026Injury2020563-2025-00012
- CanonJan 5, 2026Injury2020563-2025-00013
- CANONOct 27, 2025Malfunction23390301
- XRAY CAMERAJun 1, 2022InjuryMW5110044
Recalls
2 on file
- TerminatedMay 25, 2013
Canon Inc. had received 17 claims from our foreign sales companies between October to November 2012 that measurement value of RK-F2s refractive power (SPH value) sometimes indicated abnormal value which occurs approximately 5% in probability.
View FDA record ↗ - TerminatedAug 24, 2012
Screws holding the 55REF circuit board are loosening and roaming inside of the sealed sensor.
View FDA record ↗
Compliance history
Matched by FEI 3002808382.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
1 on file
Top refusal reasons
Compare to industry ↗- Division of West Coast Imports (DWCI)Feb 24, 2025
90LNH \ SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING